This invention comprises a medical system and a method of controlling the system for use by a patient for medical self treatment.
For a number of years it has been possible to purchase various devices for the treatment of diabetes, e.g. for injecting insulin, for measuring blood sugar (such a device is referred to as BGM in the following), for withdrawing blood samples, and other accessories, the purpose of which is to enable the patient to nurse his disease discretely and with a high standard of safety.
Many diabetic patients are elderly people who can easily get insecure with respect to the medical equipment. It is very reassuring and therefore also very important that the user can have feedback from the system which confirms to the user that everything is OK right from the technical function of the system to the patient""s physiological condition. This stretches out a psychological safety net under the patient, which contributes to improving the quality of life of patients having a disease such as diabetes.
Also many young people need to assure themselves that the equipment is in order, i.e. calibrated, powered, updated and otherwise ready to be operated.
One way of ensuring that you have all the things needed ready at hand is to build several of the necessary devices together into a single integral unit, see e.g. U.S. Pat. No. 5,536,249 and No. 5,593,390. This is not an ideal solution since such a multi-functional device is usually quite complex both with respect to manufacture and use. People need to be familiar, secure and confident with the use of a device for self-treatment which such an integral multi-functional device does not provide.
Another drawback of integrating several functions in one apparatus is that owing to the commercial outlets the manufacturer never integrates all possibilities, but just the most important ones, in order for it to be relevant to a sufficiently large group of users. The functions which are thus not integrated must be provided by means of separate apparatuses typically of different makes, which can easily create uncertainty as to whether the apparatuses work correctly together.
Additionally, the functionality and the individual devices of an integral multi-functional device are very hard if not impossible to update without updating everything else.
According to the invention the individual devices may be arranged for various respective functions relevant to the treatment of e.g. diabetes, such as: a lancet device, a body fluid analyser, one or more drug administration apparatuses for administering a predetermined dose of medication to the patient. Further, there is a number of other aids which the diabetic patient uses, e.g. test strips for the blood analyser, needles, napkins for wiping off blood, extra insulin cartridge, glucose tablets, waste containers, etc.
The object of the invention is to provide a method for effective monitoring of electronic data relevant to a plurality of apparatuses/units which are used by a patient for self-treatment of a disease, so that a greater level of safety, both functionally and emotionally, and an effective feedback to the patient are obtained.
This is achieved according to the invention in that the individual apparatuses are provided with electronic communications equipment so that the apparatusesxe2x80x94when in a state of mutual communicationxe2x80x94frequently exchange information between them. Hereby a greater functional safety can be achieved and the total data capacity of the system can be increased, so that the feedback possibilities, e.g. of the system checking that every apparatus is OK and set up properly and of the patient be given a number of possible choices to choose from in a given situation, are increased.
More particularly, the invention relates to a method of controlling data information between a plurality of portable apparatuses for use by a patient for medical self treatment, the treatment including a first operation and at least a second operation, said portable apparatuses comprising a first apparatus for performing the first operation, and at least a second apparatus for performing the second operation, wherein each apparatus belonging to the medical self treatment has means for one or more of the following: storing, transmitting, receiving, processing and displaying information, an attempted data communication between said apparatuses is initiated on request, said communication being controlled by a functional master module, and designating said functional master module among at least two of said apparatuses.
The request can e.g. be initiated by a timer or other external events such as the patient performing an action. The invention provides the specialeffect that a patient need not bring along a large apparatus technically complicated in use in order to treat his disease, but that the apparatus may be divided into several smaller and simpler units capable of communicating mutually. The individual units may optionally be adapted to be interconnected mechanically, as disclosed in Danish Patent Application No. PA199800714.
According to the invention, all apparatuses need not be active for communication to be established between some of the apparatuses. This requires that all the apparatuses are adapted to a specific communications protocol, there being several options in this respect. For example, one of the units may be provided with program information of highest priority with respect to the control and monitoring of data communication between the individual apparatuses and being designated as the functional master module, where the program information of highest priority may either be activated in or transferred to the designated functional master module. The unit of highest priority may very well be turned off by the user or even be broken, because the apparatuses may be adapted to communicate directly with each other and perform storage of information, which is subsequently transmitted to the unit of highest priority when this is again in communication with another of the apparatuses.
Preferably a protocol where a number of potential master modules (unit of highest priority) is predefined. These predefined potential master modules are given a hierarchical priority and the potential master module with the highest priority among the activated and present potential master modules becomes the functional master module. This master module polls the other activated and present apparatuses for information.
In this way, when the user selects some of the apparatuses and takes them with him for a shorter or longer period of time, he still has a group/subset of apparatuses relevant to his self treatment which communicates/exchanges information with each other, where the designated functional master module is responsible for controlling the communication between the subset of apparatuses. The functional master module may receive and store/mirror all the information provided by/at the individual apparatuses for backup purposes, and for processing and collecting of information and an easier update with an overall master module (the one with the highest hierarchical priority), since it contains a mirror of all the information/data. Additionally the functional master module is responsible for controlling the transmission of relevant data, e.g. received from another apparatus, to the appropriate apparatus(es).
If the functional master module becomes unavailable, the individual apparatuses may just store the information locally until the master module becomes available or initiate the designation of a new functional master module, i.e. the one with the highest available priority.
U.S. Pat. No. 5,204,670 discloses a system for monitoring and identification which has a master module which transmits information collected from different sensors to a central system for further processing. It mentions the possibility of using software and hardware modules to implement a flexible system, but once the selection of modules has been made, the system and configuration are static.
WO 98/02086 discloses an inspection and measurement system where a simple terminal is installed in a house of a patient with a data collector and where a central control unit collects information from a number of terminals (located in different houses).
None of the two specifications discloses a system where a portable set, e.g. subset, of apparatuses can communicate and exchange information, relevant to a self treatment of a disease, with each other, and thus they do not provide a flexible system with greater functional safety and better feedback possibilities arising from the mutual exchange of information between the apparatuses.
Alternatively, other communications protocols may be implemented such as:
A protocol for a self-organizing network where every apparatus retransmits all the received information until the apparatus or apparatuses that the information was meant for receive it. In this way every apparatus functions as a relay station or as a functional master module and a temporary storage of transmitted information. This structure is especially useful when the configuration of the network is not known or when the configuration of the network changes in an unpredictable manner. Another feature of a network of this kind is that a maximal number of redundant transmission paths with a buffer are created so that the system can transmit information to apparatuses that were not available when the information was transmitted.
A protocol where all the apparatuses transmits their information without any supervision of any kind. The apparatuses themselves have to decide what information is relevant for them.
One single unit/apparatus, e.g. the unit of highest priority/overall master module, is preferably adapted to communicate with a larger central communication center/external system which may contain a patient database. Such further use of the invention is known e.g. from U.S. Pat. No. 5,204,670 or WO 98/02086, which, cannot however, offer the patient the flexible and safe use of a set of different apparatuses with mutual communication according to the invention which together are used in the treatment of a disease.
The apparatuses according to the invention communicate and process information such as: amount of medication, type of medication, the concentration of relevant substances in the body e.g. body fluid level/concentration, time stamp, amount of food (e.g. amount or units of carbohydrate), measurement of physical activity, notification (e.g. alert and warning) to the patient, body characteristics (e.g. weight, blood pressure etc.) and inventory logistics. This ensures that relevant information, for e.g. a drug administration system like a doser, i.e. number of units of insulin, insulin type and time and date for administering, can automatically be stored, displayed, received and transmitted to and from all the relevant apparatuses. The doser could also receive information regarding a predetermined number of units of insulin to be administered and automatically set the amount of medication to be administered by electromechanical means. In this way elderly and handicapped people do not have to set the relevant amount of medication themselves but just activate the doser.
Other types of drug administration systems like an inhaler adapted to administer a dose of medication in an air stream or a tablet dispenser may be included instead or in combination with the doser. The inhaler and/or tablet dispenser may also communicate with the other units for relevant information like the doser according to the invention.
Additionally, different types and makes of apparatuses may be provided like e.g. a simpler backup doser, which for a shorter period replaces one of the normally used dosers e.g. temporarily out of order, a special doser particularly suited for sports, e.g. by being more robust, or apparatuses which have different color schemes and/or design (e.g. for kids, etc.).
It is especially useful to transmit the data from all apparatuses to the apparatus responsible for communicating with external systems for safe keeping, calibration, synchronisation and updating of data and possible transmission to e.g. an external unit like a PC or database for further data acquisition, storage and processing. In this way the patient, a physician or an expert care-team can obtain the behavior over time of the patient, a a check for compliance to a diet or treatment given to the patient by a physician or an expert care-team can be made. This could also be done automatically.
Additionally, it is also possible for the patient to manually input information about the treatment. This information may be historic information as well as information about a future scheme (behavioral pattern) e.g. planned physical exercise, administering of insulin, intake of food and other medications. This information may be collected and thus serve as an electronic diabetes diary or may be used to notify the patient through the receiving means as to whether the planned actions are dangerous or not.
It is evident that since the apparatuses are to be carried by the patient, there is a potential lack of space for an advanced input device e.g. a keyboard. Therefore, information which cannot be input on a standardized form e.g. personal comments on the treatment is types into the apparatus by the patient using a simple input device once and can subsequently be chosen from a list if needed again.
The patient can further receive recommended amounts of medication, exercise, food, etc. from a physician, from an expert-team or automatically.
Additionally, since only one unit provides a link between the system and any outside systems, the great advantage that only one unit needs to be updated with respect to external communications protocols, etc. if the outside systems specifications change, is achieved.
All the apparatuses of the system may exchange information so that every apparatus (or at least every apparatus within range) is updated with the total information, so that every bit of information is mirrored for better safety and backup, but preferably one particular apparatus is still the link to any outside systems. This demands a greater amount of total memory capacity for the system, but with the ever decreasing price (and size) of memory modules that may be irrelevant.
Alternatively, the individual apparatuses are just updated with information relevant to them and send their information to one overall or one temporarily unit of highest priority, i.e. functional master module.
The invention also relates to a medical system for use by a patient for medical self treatment, the treatment including a first operation and at least a second operation, the apparatus comprising a first apparatus for performing the first operation and a second apparatus for performing the second operation, wherein each apparatus comprises means for storing, processing and/or displaying information, and comprises means for transmitting and receiving information so that each apparatus is able to exchange data with any of the other apparatuses belonging to the self treatment, at least two of said apparatuses being a potential functional master module, one of said potential functional master module being designated as the functional master module, and that said functional master module is adapted to control an attempted data communication, initiated on request, between said apparatuses.
For a BGM according to an embodiment of the invention the relevant information could be the time and date for measurement, measured level/concentration of blood glucose that could be stored or transmitted to another apparatus.
For a doser according to an embodiment of the invention the relevant information could be the type of medication (e.g. long acting or short acting insulin), number of units of insulin to be administered and the time and date of the administering. This information could either be set mutually by the patient or remotely by a physician, an expert care-team or automatically.
For an insulin according to an embodiment of the invention the relevant information could be the type of medication, the number of units of medication to be administered and the time and date of the administering. This information could either be set manually by the patient or remotely by a physician, an expert care-team or automatically.
For a storage container according to an embodiment of the invention the relevant information could be used to keep track of the contents of the container so that every time an object (e.g. cartridge, needle, etc.) is used, the storage container will update the inventory list. This list could be transferred to an unit of highest priority immediately or later, which could in turn update the patient""s total holdings of objects, so that the system could notify the patient when he should order a new stock of objects. The ordering could also be done automatically by the system if the inventory list is transferred to an external unit, which greatly improves the confidence, comfort and safety of the patient.
For a tablet dispenser according to an embodiment of the invention the relevant information could be the number of dispensed tablets, the number of remaining tablets, the time of dispension and the type of dispensed tablets. The dispenser could store and/or communicate this information to an available unit of highest priority or other units within communication range.
In the following a preferred embodiment according to the invention is described in detail. This particular embodiment is meant as one example only of the invention and should not as such limit the scope of protection.
In the preferred embodiment a specific simple communication protocol has been chosen to simplify the explanation of the invention. In the chosen protocol a predefined apparatus is chosen as the unit of highest available priority (functional master module) which controls, coordinates and monitors the mutual data communication between all the apparatuses including itself. The master module collects or mirrors all the data stored in the other apparatuses. This collected or mirrored data can then be redistributed to the overall master module, any of the other apparatuses and/or an external unit (e.g. a personal computer or database system) for later retrieval and/or processing.
According to the invention the portable system can operate even if the overall master module is not present, since all the relevant apparatuses comprise internal storage means, so that they can store the relevant information when it is obtained and transmit it when they can reach the overall master module once again or transmit it, as described above, to the functional master module.
Preferably the information obtained is kept in the apparatuses so that the patient on request always can be presented with the latest measurements and/or information obtained or received.
A person skilled in the art could easily implement other communication protocols such as the ones described above.
In this embodiment a cap unit for a doser has been designated as the functional master module but any apparatus could have been chosen just as easily. Preferably, the master module will be the apparatus that the patient carries most often.